The efficacy of INCRUSE ELLIPTA in combination with an ICS/LABA was evaluated in 4 randomized, double-blind, parallel-group trials in subjects with COPD. These trials, all of similar study design, were of 12-weeks' treatment duration. Subjects were randomized to INCRUSE ELLIPTA mcg + ICS/LABA or placebo + ICS/LABA. Entry criteria for subjects enrolled in these trials were similar to those described above in Section . The primary endpoint for these trials was change from baseline in trough (predose) FEV 1 at Day 85 (defined as the mean of the FEV 1 values obtained at 23 and 24 hours after the previous dose on Day 84). Baseline FEV 1 was measured while subjects were on background ICS/LABA.
Low temperature (refrigeration and freezing) : Most organisms grow very little or not at all at 0 o C. Perishable foods are stored at low temperatues to slow rate of growth and consequent spoilage (. milk). Low temperatures are not bactericidal. Psychrotrophs, rather than true psychrophiles, are the usual cause of food spoilage in refrigerated foods. Although a few microbes will grow in supercooled solutions as low as minus 20 o C, most foods are preserved against microbial growth in the household freezer.